Kornimate/medical-research-clean huggingface dataset:
anti-xa assay correlation to the efficacy and safety of enoxaparin in the treatment of pulmonary embolism

Conditions: Anti-Xa Assay in Pulmonary Embolism

Summary: the aim of the present study is to monitor anticoagulant therapy by anti-xa assay and correlate its level to the efficacy and safety of enoxaparin in the treatment of pulmonary embolism.

this prospective randomized trial was conducted on 42 patients 18 years of age or older in icu diagnosed to have pulmonary embolism and confirmed by the presence of intraluminal filling defect in ct pulmonary angiography and treated with subcutaneous enoxaparin 1 mg/kg/12 hours. the study was conducted from august 2013 to september 2016. all the patients were examined daily over a period of 4 weeks for symptoms and signs of recurrent pulmonary embolism (recurrent pulmonary embolism was diagnosed if the repeat ct angiography revealed a new sudden arterial branch cutoff or a new intraluminal filling defect that was not present on the first angiogram), platelet count (patients with platelet count less than 50,000/mm3 or those with bleeding and platelet count between 50,000 and 100,000/mm3 are considered having severe thrombocytopenia), bleeding (defined as major overt bleeding requiring blood transfusion \> 2 units or marked hemoglobin drop \> 2 gm/dl or if the bleeding was intracranial or retroperitoneal) and death (defined as all deaths occurring within the 4 weeks of the study) , then the results were correlated to anti-xa assay.

Eligibility criteria:
inclusion criteria: * patients in icu and diagnosed to have pulmonary embolism and confirmed by the presence of intraluminal filling defect in ct pulmonary angiography and treated with subcutaneous enoxaparin 1 mg/kg/12 hours. exclusion criteria: * patients who underwent thrombolysis, embolectomy or if they are unfit for anticoagulant therapy because of major bleeding or thrombocytopenia (a platelet count below 100,000 per cubic millimeter). patients were also excluded if they had impaired kidney function with a serum creatinine level above 2 mg/dl or uncontrolled hypertension (blood pressure \> 160/100 mmhg).
baby bump lifestyle intervention supplement study

Conditions: Gestational Diabetes

Summary: the overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.


Eligibility criteria:
inclusion criteria: * pregnant woman presenting to her first obstetrical visit for this pregnancy * must be in the first trimester (\<13 weeks) * 18 years or older * high-stress levels as measured by the perceived stress level questionnaire * must be a single pregnancy (e.g. not twins, triplets, etc.) exclusion criteria: * diabetes (types 1 and 2) * diagnosis of gestational diabetes in prior pregnancy * hyperemesis gravidarum or severe morning sickness that interferes with supplement intake * major medical illnesses including but not limited to: malabsorption syndromes (celiac's disease, crohn's, ulcerative colitis), systemic lupus erythematosus and other major autoimmune conditions
topical cbd for musculoskeletal pain

Conditions: Pain

Summary: various otc and cbd containing topicals are evaluated in a double blind survey. each sample has a qr code that is to be scanned before applying. the qr code links to a survey form with application instructions and collects participant information and feedback.


Eligibility criteria:
inclusion criteria: * has pain exclusion criteria: -
effect of pioglitazone on insulin resistance and atherosclerosis in renal allograft recipients without diabetes

Conditions: Kidney Transplantation; Insulin Resistance; Atherosclerosis

Summary: the aim of this study was to evaluate the effect of pioglitazone treatment on insulin secretion, insulin resistance, and progression of atherosclerosis in renal allograft recipients without preoperative history of diabetes.

this is a prospective, randomized, open-label study. the pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months. after treatment, we estimated insulin sensitivity index for transplantation,first phase and second phase insulin secretion, secretion area under the curve,and carotid intima-media thickness.

Eligibility criteria:
inclusion criteria: * renal allograft recipients were eligible to participate in the study if they were aged ≥ 18 years, had no previous history of organ transplantation and were not currently using steroids or other immunosuppressants. exclusion criteria: * diabetes before transplantation * severe metabolic or infectious disease * hepatic disease * congestive heart failure (new york heart association ii-iv) * cadaver donor kidney donor transplantation * unstable condition of the transplanted kidney

Keywords: kidney transplantation thiazolidinediones insulin resistance atherosclerosis
ultra-fractionated radiotherapy for rectal cancer

Conditions: Rectal Cancer

Summary: the rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. we believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response.

to determine the maximal tolerated dose (mtd) of dose-escalated hypofractionated adaptive rt, in patients with locally advanced rectal cancer treated with rt, folfox (5-fu, oxaliplatin, leucovorin) or capox (capecitabine, oxaliplatin) chemotherapy and selective omission of surgery.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age. both men and women and members of all races and ethnic groups will be included. 2. willing and able to provide written informed consent 3. pathologic diagnosis of rectal adenocarcinoma 4. t3-4 and/or n+ disease per ajcc 8th edition 5. no prior treatment for rectal adenocarcinoma 6. eastern cooperative group (ecog) performance status of 0-2. 7. laboratory values supporting acceptable organ and marrow function within 30 days of eligibility confirmation. defined as follows: * wbc ≥ 3,000/ml; * anc wbc ≥ 1,000/ml; * plt ≥ 75,000/ml; * t bili ≤ 1.5 x upper limit of normal (uln); * ast/alt ≤ 2.5 x uln; * creatinine not above uln, or creatinine clearance \>50 ml/min/1.73 m\^2 for participants with creatinine levels above institutional normal. 8. all men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first dose of study therapy through 90 days after the last dose of study drugs. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. a female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * has not undergone a hysterectomy or bilateral oophorectomy; or * has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). exclusion criteria: 1. distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by ct. 2. prior rt to the pelvis. 3. uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements. 4. psychiatric illness/social situations that would limit consenting and compliance with study requirements. 5. participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants

Keywords: rectal cancer,t3-4 or n+
a study for treatment of partial seizures in children

Conditions: Partial Seizures

Summary: the purpose of the study is to assess the safety profile of the investigational medication, depakote sprinkle capsules, in the treatment of partial seizures in children ages 3-10.


Eligibility criteria:
inclusion criteria: subject has diagnosis of partial seizures with/without secondary generalization, supported by: * observed ictal events consistent with partial seizures with/without secondary generalization; documented by reliable observers * 1 of following 3: * eeg at some time in past demonstrating focal abnormalities consistent with partial seizures * if the eeg is inconclusive or does not support partial seizures, then an mri/ct will be done * if the mri/ct fails to support a diagnosis of partial seizures, the subject may still qualify based on the principal investigator's clinical diagnosis * subject weighs at least 15 kg (33 lbs). * parent/caregiver is able to keep an accurate seizure diary. exclusion criteria: * has had status epilepticus in the past 3 months prior to screening * has a history of any of: cardiac (including clinically important abnormality on ecg); renal; psychiatric (including psychosurgery); oncologic; endocrine; metabolic; pancreatic; hepatic disease (including clinical/serological history of hepatitis); urea cycle disorder * has: expanding cns neoplasm; active cns infection; demyelinating disease; degenerative neurological disease; progressive encephalopathy; or any progressive cns disease * has platelet count less than or equal to 100,000/mcl * has blood chemistry alt/ast value(s) greater than or equal to 2 times upper limit of normal at screening * requires anticoagulant drug therapy * receiving systemic chemotherapy * requires treatment with aspirin * subject is pregnant * has been on ketogenic diet within 30 days prior to screening * considered by investigator to be non-responder to valproate for treatment of epilepsy (e.g., despite adequate trial with serum concentrations of 60 mcg/ml or greater, subject continues to have inadequate seizure control)

Keywords: partial seizures
intravenous high dose nac and sodium bicarbonate for the prevention of contrast-induced acute injury

Conditions: Acute Renal Failure

Summary: contrast-induced acute kidney injury is a common cause of acquired in-hospital renal insufficiency and is associated with prolonged hospitalization and unfavorable early and late outcomes. the investigators sought to compare 4 different strategies (intravenous high-dose of n-acetylcysteine, sodium bicarbonate, the combination of both, and saline alone) in the prevention of contrast-induced acute kidney injury in patients undergoing coronary angiography using high-osmolar contrast media defined by creatinine and cystatin c serum levels.


Eligibility criteria:
inclusion criteria: * eligible patients include individuals aged 18 year or older with normal renal function who were schedule to undergo cardiac catheterization. during the randomized study, consecutive eligible patients schedule for exposure to the ionic, high osmolality (2130 mosm/kg) contrast agent ioxitalamato. exclusion criteria: * using metformin or nonsteroidal antiinflammatory drugs within the previous 48 hours * intake of nephrotoxic drugs during the previous seven days * pregnancy * lactation * intravascular administration of an iodinated contrast medium within the previous two days * emergency catheterization * pulmonary edema * acutely decompensate congestive heart failure * history of serious reactions to iodinated contrast mediums * renal transplantation * end-stage renal disease necessitating dialysis

Keywords: n-acetylcysteine angiography contrast medium contrast-induced nephropathy sodium bicarbonate
fast titration of quetiapine versus currently approved titration

Conditions: Psychotic Disorders

Summary: the purpose of this study is to evaluate the safety and tolerability of a more rapid dose titration in acute schizophrenic patients compared to the conventional titration.


Eligibility criteria:
inclusion criteria: * signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. should stay in hospital for at least 7 days. exclusion criteria: * patients treated with risperdal consta or clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.

Keywords: schizophrenia schizoaffective disorder
frequency analysis of the ultrasound images in rotator cuff tendon

Conditions: Rotator Cuff Injuries

Summary: previous studies used spatial frequency analysis of tendon ultrasound images and considered that the parameters can reflect the micro-structure of the tendon. in this study, we try to recruit and analysis the rotator cuff tendon in healthy adults with different ages and different equipment to explore the the normal range and differences of spatial frequency parameters. the hypotheses of this study are (1) the young and the elderly would have significantly different spatial frequency value; and (2) there would be significant different results between different equipment.

tendons are hierarchical fibrous tissues. the speckle signals of ultrasonic images have parallel stripes arranged along the long axis of the tendon, reflecting the arrangement of collagen fiber bundles in the tendon. the micro-structure of tendons can be quantified by analyzing the speckle pattern of ultrasonic images. a research team used fast fourier transform to convert ultrasound images of tendons into two-dimensional spatial frequency spectra, and used linear discriminate analysis to calculate multiple spatial frequency parameters. the results indicated that there were 5 parameters with the highest accuracy in discriminating achilles tendinopathy. there is a significant difference in the spectrum frequency parameters of whether the tendon was loaded and whether there was a tendinopathy tendon. past studies using spatial frequency analysis in patients with shoulder pain, and they found that there was no significant difference between the asymptomatic control group and shoulder pain patients. the risk factors of rotator cuff tendon injury is related advanced age, dominant hand, and repeated overhead activities. therefore, in this study, we will recruit participants of different ages and investigate the results of spatial frequency analysis of bilateral shoulders ultrasound images. the aim of this study is to know whether these factors may affect the micro-structure of the rotator cuff tendons and establish the reference norm of spatial frequency analysis parameters in those without obvious tendon degeneration or injury. in addition, we aim to compare the differences between spectrum analysis parameters with several instruments by using different ultrasonic equipment. this study could provide a reference for the clinical application of spatial frequency analysis in tendon ultrasound images.

Eligibility criteria:
inclusion criteria: * (1) age between 20-40 or age over 60; * (2) no bilateral shoulder pain or discomfort within six months; * (3) no past diagnosis in shoulder or upper extremities. exclusion criteria: * (1) fracture of upper extremities before; * (2) be diagnosed as neck radiculopathy, central nervous system lesion of brain, or peripheral nervous system lesion of upper extremities; * (3) rheumatoid arthritis or autoimmune disease; * (4) have received any shoulder injection or surgery; * (5) tendon tear in shoulder sonograms.

Keywords: ultrasonography rotator cuff tendon
extended access of momelotinib in adults with myelofibrosis

Conditions: Neoplasms; Post-polycythemia Vera Myelofibrosis (Post-PV MF); Primary Myelofibrosis (PMF); Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)

Summary: the primary objective of this study is to provide extended access and assess long-term safety of momelotinib (mmb) in participants with primary myelofibrosis (pmf) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-pv/et mf) enrolled in studies gs-us-352-0101 (nct01969838), gs-us-352-1214 (nct02101268), gs-us-352-1154 (nct02124746), sra-mmb-301 who are currently receiving treatment with mmb (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. the secondary objective is to assess overall survival (os) and leukemia free survival (lfs) in all subjects.


Eligibility criteria:
key inclusion criteria: * currently enrolled in studies gs-us-352-0101, gs-us-352-1214, gs-us-352-1154, or sra-mmb-301 * able to comprehend and willing to sign the informed consent form key exclusion criteria: * known hypersensitivity to mmb, its metabolites, or formulation excipients note: other protocol defined inclusion/ exclusion criteria may apply.
effectiveness comparison of skin micro-grafts vs meshed split thickness skin grafts

Conditions: Skin Ulcer; Burns

Summary: this is a double-blind randomized controlled clinical trial, that compares the percentage of epithelialization of skin defects using the conventional meshed split thickness skin grafts vs skin micro grafts. two techniques will be applied in the same patient. the skin defect will be divided in two parts, and with a randomized method each half of this defect will be assigned to one of the two techniques.

split thickness skin graft is the standard technique in skin defects reconstruction. the etiology of this problem is diverse (burns, infections, trauma, cancer) however, many times the availability of donor areas are insufficient and morbidity and complications that may arise make prohibitive the use of this technique in many situations. skin micro grafts technique consists in using a very small part of skin (0.8x 0.8 mm) and keratinocyte growth-factor solution that allows a 1:50- 1:100 skin expansion. it has many advantages: it can be performed with local anesthesia and donor area is tiny. the study consists in using the conventional and the new technique in the same patient. the skin defect will be divided in two parts, and with a randomized method each half of this defect will be assigned to one of the two different techniques. the result variable will be the "percentage of epithelialization" and will be compared in the two halves. this variable will be measured at day 14 using clinical and image software methods. the patient and the investigator that record the outcome variable will be blinded to the type of technique. the investigators will take skin biopsies of two halves and will perform pathology studies.

Eligibility criteria:
inclusion criteria: * non complicated wounds (no infection, no cancer) * wound area: 20 x 20 cms or less * located in diverse anatomical regions (except axillar, groin, genital, sole, scalp and flexion or extension areas) exclusion criteria: * high cardiovascular risk * patients with indication of a different technique

Keywords: skin transplantation grafting skin
study to investigate the influence of hepatic insufficiency on the pharmacokinetics of tozadenant

Conditions: Hepatic Impairment

Summary: this is a two-part, open label, single-dose study that will evaluate the pk of tozadenant in subjects with different degrees of hepatic impairment to the pk of a single-dose of tozadenant in healthy subjects.


Eligibility criteria:
inclusion criteria: all subjects must fulfill the following to participate: * subject has given his/her written informed consent on an iec or irb approved consent form. * subject understands the study procedures in the informed consent form (icf), and is willing and able to comply with the protocol. * be either male or female 18 years old * have a bmi ≥ 18.5 and ≤ 40.0 kg/m2 at screening * is a continuous non-smoker or a smoker who will consume up to 10 cigarettes/day * child bearing females should be sexually inactive (abstinent) prior to dosing * females subjects of non childbearing potential must have undergone one of the following sterilization or be postmenopausal subjects with mild, moderate, or severe hepatic impairment must: * have a medical history consistent with a diagnosis of hepatic impairment. * have a diagnosis of chronic (\> 6 months), stable hepatic insufficiency healthy subjects must be: * medically healthy with no significant medical history exclusion criteria: subjects must not be enrolled in the study if they: * previously participated in any study with tozadenant * has orthostatic hypotension, history or symptoms of cardiovascular disease, or hypertensive crisis. * currently participating in or has participated in another study and received drug (active or placebo) * have a known diagnosis of malignant melanoma * have a current episode of major depression * has a recent history of suicide attempt * has any other condition or clinically significant abnormal findings on the physical or neurological examination, psychiatric and medical history * had surgery or any medical condition within 6 months * unable to refrain from or anticipates the use of any drugs, vitamins, natural or herbal supplements * subject is currently lactating or pregnant or planning to become pregnant. * recent donation of blood, plasma or significant blood loss * has positive test for ethanol or drugs of abuse or a history of chronic alcohol or drug abuse * clinically significant medical history * positive results hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) for healthy volunteers only.

Keywords: adults liver disease
a study to test the effect of mk0217a on vitamin d inadequacy in postmenopausal women with osteoporosis (0217a-262)

Conditions: Osteoporosis

Summary: a study designed to see if the study drug will increase blood levels of vitamin d, bone mineral density (bmd), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.


Eligibility criteria:
inclusion criteria: * female * 65 years or older * diagnosed with osteoporosis (bone mineral density (bmd) t-score \<= -2.5 at spine or hip) or prior fragility fracture bmd t-score \<=-1.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck sites * postmenopausal * low levels of vitamin d as measured 25-hydroxyvitamin d * has fallen at least once within the past 12 months exclusion criteria: * unable to stand or sit upright for at least 30 minutes * has a bone disorder other than osteoporosis * contraindication to the use of fosavance